Status:
COMPLETED
Safety, Tolerability, Pharmacokinetics of hzVSf-v13 in Healthy Adults (Intravenous and Subcutaneous Administration)
Lead Sponsor:
ImmuneMed, Inc.
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
Assessment of the safety, tolerability and pharmacokinetics (PK) characterization of hzVSF-v13 with single and multiple doses (intravenous and subcutaneous) compared to placebo in healthy subjects.
Detailed Description
A phase I, double-blind, placebo-controlled, single and multiple dose
Eligibility Criteria
Inclusion
- Males or females (of either childbearing or non-childbearing potential), of any race, between 18 and 60 years of age, inclusive on day of screening.
- Body mass index between 18.0 and 32.0 kg/m2, inclusive on day of screening.
Exclusion
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee).
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee).
Key Trial Info
Start Date :
September 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 7 2022
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT04817202
Start Date
September 16 2020
End Date
July 7 2022
Last Update
February 15 2024
Active Locations (1)
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1
CMAX, Clinical Research Pty Ltd.
Adelaide, South Australia, Australia, 5000